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During a recent trip to the National Institutes of Health to provide a donation of white blood cells to the ‘long-term non-progressors’ (LTNP) Study, I had the occasion to meet two scientists launching a new Pilot Study called “White Blood Cell Infusion for the Treatment of HIV Infection”.

Dr. Kovacs and Dr. Pooran, the primary investigators (PI’s), were very kind to take the time out of busy schedules to discuss this ‘new frontier’ of possible treatment -- and to share their hope for success to halt the progression of HIV disease -- with an unprecedented approach otherwise known as a “Cell Transfer”.

I am posting a descriptive document for you today that outlines the specific details of this study, what they hope to accomplish, who the donor (s) and recipient (s) will be, and what is involved to be considered an eligible candidate for this Pilot Study.

In order for this study to begin, eligible recipients must be found. Basically, what we are talking about is an individual (a “progressor”) who tests positive for the gene HLA B*5701, has a CD4 count of 200 (or less), a viral load of 10,000 (or above), and has failed two or more regimens of medications for HIV. This also means someone who has not been successful with ‘rescue therapy’ (or ‘salvage therapy’).

We are talking about someone who may have run out of options.

Eligible donors are those of us who have been categorized as ‘Elite Controllers’, and who carry the B*5701 gene (among other specifics outlined in the document). (Tim Horn was very kind to provide the following information about testing for this gene: “One way to explain the HLA-B*5701 testing is that this is now highly recommended for anyone starting either Ziagen or Epzicom for the first time, as it is the gene believed to be responsibility for abacavir hypersensitivity. Now that the test for 5701 is widely available -- and quite cheap -- most doctors are performing it regularly. Even for those who aren't considering an abacavir-containing regimen, its good for people to have their HLA-B*5701 status on file (it doesn't change at any point in a person's life) for future reference, should an abacavir-containing regimen need to be started sooner than later.)

Words cannot describe the excitement I felt when I listened to these men speak about this amazing procedure, and the fact that research is going to turn science ‘fiction’ into science ‘reality’. Think about it – my white blood cells will be extracted and literally ‘transferred’ into another person, in the hope to share some of my own ‘natural controls’ of HIV with them. Truly an astonishing event, and even more so if it works!

Please share this information widely to your networks! Dr. Kovacs and Dr. Pooran appealed to me to help them in their search for recipients, and it is my pleasure to do so. I know I can count on the AM Forum Family to assist – collectively, we have the ability to get the word out!

Thanks for your help.

Below is the NIH document:

National Institutes of Health, National Institute of Allergy and Infectious Diseases HIV ResearchNational Institute of Allergy and Infectious DiseasesNational Institutes of Health

Name of Study: Immunologic and Virologic Response in HIV Infected HLA-B*57 Progressors after Infusion of Lymphocytes from HIV Infected HLA-B*57 “Elite” Long-term Non-progressors

Goal of Study: To determine the safety and duration of survival of donor lymphocytes following infusion.

Description of Study: This research study at the NIH Clinical Center will evaluate the safety and provide preliminary information about the anti-HIV activity of an investigational therapy that involves infusing cells obtained from an HIV-infected patient who is able to control HIV replication without therapy into a patient who is unable to control HIV replication. A subset of individuals who are HLA-B*57 positive (HLA is a protein found on the surface of white cells) are able to control HIV replication to less than 50 copies/ml (non-progressor), presumably by an immune-based mechanism. Other individuals with HLA-B*57 show no evidence of control of HIV replication, and without antiretroviral therapy will develop progressive immunodeficiency and HIV-related opportunistic complications (progressor). In this exploratory study, white blood cells obtained by apheresis from HLA B*57+ long-term non-progressors will be given to HLA B*57+ progressors who have failed at least 2 standard regimens of antiretroviral therapy, have a CD4+ count under 200 cells/mm3, and a plasma HIV viral load of >10,000 copies/mL. Recipients will be monitored for side effects and to see how long the infused cells can be detected; immune and viral markers will also be followed. Two additional cell infusions can be given, with at least 3 months between infusions. The study is seeking both donors and recipients. Up to 3 donors and 3 recipients will be eligible to participate. Donors will be compensated.

Inclusion and Exclusion Criteria: Both Donors and Recipients for this protocol must be HIV infected individuals at least 18 years old, HLA-B*57 positive, and have no significant other underlying medical problems. Additional Inclusion Criteria, Recipient• Failure of at least two previous combination regimens, one containing an NNRTI and one containing a protease inhibitor• Viral load >10,000 copies/mL and CD4+ cell count < 200 cells/mm3 on combination antiretroviral therapy- Patients not on combination antiretroviral therapy will be eligible, but must be willing to resume therapy and to have had a viral load >10,000 copies/mL after at least 2 weeks of therapy Additional Inclusion Criteria, Donor• CD4+ cell count ≥ 400 cells/mm3 and HIV viral load < 50 copies/mL, with no recorded HIV viral load > 1,000 copies/mL.• HIV infection for ≥ 7 years and not on antiretroviral therapy• Minimum weight of 110 lbsExclusion Criteria, Recipient• Malignancy requiring systemic therapy, or chemotherapy which is toxic to the bone marrow.• Current untreated opportunistic infection • Pregnancy or breast feeding.• Current or recent use of a systemic corticosteroid, immunosuppressive or cytotoxic agent, or investigational agent • History of autoimmune vasculitis Exclusion Criteria, Donor• Any history of an AIDS-defining illnesses• Prior antiretroviral therapy other than one or two nucleotide reverse transcriptase inhibitor (NRTI) drugs; no therapy during the previous year• Active Hepatitis B infection, active or prior Hepatitis C infection• History of malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of cervix or colonPerson to Contact: Mr. Rocco Caldararo at caldararor@niaid.nih.gov or 301-402-3481Link to Study: http://clinicaltrials.gov/ct2/show/NCT00559416?term=NIHCC+%5BORGANIZATION-NAME%5D+AND+HIV+%5BCONDITION%5D&rank=28

bmancanfly: won't the recipients body just reject the transferred cells as foreign?

Good question. That's probably one of several reasons why it's a safety study along with endurance. The text below is from the American Cancer Society website. In this NIH study, non-related parties should make a difference and this is not infusion of whole blood. I'm including the ACS info only because of the white cell reference in the NIH study.

Graft-versus-host disease (GVHD): GVHD occurs when white blood cells in transfused blood attack the tissues of a transfusion recipient who has a severely weakened immune system. It is more likely to happen if the person getting the blood is a relative or has a similar tissue type to the donor. The recipient's immune system doesn't recognize the white blood cells in the transfused blood as foreign. This allows them to survive and attack the recipient's body tissues. Within a month of the transfusion, the patient may have fever, liver problems, rash, and diarrhea. To prevent white blood cells from causing GVHD, donated blood can be treated with radiation before transfusion. Radiation stops white blood cells from working but does not affect red blood cells.

bmancanfly: won't the recipients body just reject the transferred cells as foreign?

[...]

Graft-versus-host disease

Hi, Emeraldize!

Did I misunderstand or did "bmancanfly" raise the opposite issue (host vs. graft)?

Anyway, in the "Detailed Description" of the trial, I read: "Up to 70 patients may be enrolled for screening to identify 3 donors and 3 recipients". May be they will do some tests to choose the most histocompatible couples of donors/recipients?

Another question, please. The headline of the "NIH Clinical Center Detailed Web Page" (linked below "More Information" in the clinicaltrials.gov document) reads: "Active Followup, Protocols NOT Recruiting New Patients". What do they mean by that??? Quite puzzling!

Graft versus host disease IS a stated risk for the infusion recipients in this study. However, its important to note that GVHD is typically seen in immunocompromised patients following bone marrow transplantation, after the person's natural immune system has basically been wiped out with very high-dose chemotherapy.

In this study, infusion recipients will be receiving approximately 10 billion lymphocytes during one session. This number of lymphocytes is equivalent to that found in approximately 10 units of packed red blood cells. In immunocompetent patients who have received this amount of lymphocytes, the protocol clearly states, donor lymphocytes have survived for over 1 year (limited host versus graft disease) with no evidence of GVHD, indicating an apparent mutual tolerance between donor and recipient cells.

The protocol also points out that a large trial failed to show any harm HIV-infected patients receiving lymphocyte-rich blood products, compared with blood products in which lymphocytes had been removed. In a nutshell, the conclusion of this study was that HIV-infected patients do not appear to be at risk for transfusion-associated GVHD. While the protocol spells out one case report of an HIV-infected child who developed possible GVHD after receiving blood with white blood cells, the symptoms were limited and the child recovered within 4 weeks with no evidence of persistent circulating donor lymphocytes.

The researchers conclude that the likelihood of developing graft versus host disease from the infusion of lymphocytes in this study appears to be low. However, they also point out a possibility -- should GHVD occur, it may be fatal. Definitely a consideration for those thinking of participating.